Antiseptic Povidone-iodine Prep Pad

SPL v1

SPL

SPL Set ID fc76c1f3-b48e-4276-890d-5b8e5a894e62

Route

TOPICAL

Published

Effective Date 2024-04-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Iodine (100 mg)

Inactive Ingredients

Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-05-15

Description

Providone-Iodine 10% w/w (1% available iodine)

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Providone-Iodine 10% w/w (1% available iodine)

Use:

First aid antiseptic to help prevent the risk of infection in minor cut, scrapes and burns.

Question?

+1(855)924-2182

Warnings:

For external use only
Single use only

Drug Facts

Directions:

Clean the treatment area
Apply to the treatment area or operative site before surgery

Do Not Use:

in the eyes
over large areas of the body
as a first aid antiseptic for longer than one week unless
directed by a physician
on individuals who are sensitive or allergic to iodine
if package is damaged or open

Package Labeling:

Active Ingredients

Providone-Iodine 10% w/w (1% available iodine)

Inactive Ingredient:

Purified water

Stop Use and Ask A Doctor If

irritation,redness,or symptoms develops
if the condition persists or gets worse.

Keep Out of Reach of Children

Structured Label Content

Use:

First aid antiseptic to help prevent the risk of infection in minor cut, scrapes and burns.

Purpose

Antiseptic

Question?

+1(855)924-2182

Warnings:

For external use only
Single use only

Drug Facts

Directions:

Clean the treatment area
Apply to the treatment area or operative site before surgery

Do Not Use: (Do not use:)

in the eyes
over large areas of the body
as a first aid antiseptic for longer than one week unless
directed by a physician
on individuals who are sensitive or allergic to iodine
if package is damaged or open

Package Labeling:

Active Ingredients

Providone-Iodine 10% w/w (1% available iodine)

Inactive Ingredient:

Purified water

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

irritation,redness,or symptoms develops
if the condition persists or gets worse.

Keep Out of Reach of Children (Keep out of reach of children)

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "IODINE", "unii": "9679TC07X4", "classCode": "ACTIM", "strengthNumerator": "100", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Use:": "First aid antiseptic to help prevent the risk of infection in minor cut, scrapes and burns.", "Purpose": "Antiseptic", "Question?": "+1(855)924-2182", "Warnings:": "For external use only Single use only", "Directions:": "Clean the treatment area Apply to the treatment area or operative site before surgery", "Do not use:": "in the eyes over large areas of the body as a first aid antiseptic for longer than one week unless directed by a physician on individuals who are sensitive or allergic to iodine if package is damaged or open", "Active Ingredients": "Providone-Iodine 10% w/w (1% available iodine)", "Inactive Ingredient:": "Purified water", "Stop use and ask a doctor if": "irritation,redness,or symptoms develops if the condition persists or gets worse."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:05.012550 · Updated: 2026-03-14T23:02:57.214195